Expandable needle suture apparatus and associated handle assembly with rotational suture manipulation system

ABSTRACT

A surgical suturing device ( 10 ) having an axis extending between a proximal end and a distal end is operable to move a suture ( 32 ) through body tissue ( 34 ). A handle assembly ( 110 ) is coupled to an elongated shaft ( 14 ) having a hollow configuration. An actuating rod ( 16 ) is disposed to extend between the handle assembly ( 110 ) and the shaft ( 14 ). A thumb actuation assembly is coupled to a proximal end of the actuating rod ( 16 ) for moving the rod both axially and rotationally. A needle assembly ( 2 ) at the distal end of the actuating rod ( 16 ) is movable with the actuating rod ( 16 ) between an extended state and a retracted state and at various angular orientations. Bifurcated portions ( 24, 26 ) of the needle assembly ( 20 ) define a suture slot ( 28 ), the bifurcated portions having a proximate relationship when the needle assembly ( 20 ) is in the retracted state and having a separated relationship when the needle assembly ( 20 ) is in the extended state. The needle assembly ( 20 ) is biased to the retracted state and the bifurcated portions ( 24, 26 ) are biased to the separated relationship. A handle assembly ( 110 ) is operable to move the needle assembly ( 20 ) between a free suture state and a captured suture state. In an associated method of use, the needle is bifurcated to form at least one pair of arms ( 24, 26  or  26   b,    38   b ) to define a suture slot ( 28 ).

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of Provisional Application Ser. No.60/604,243 filed on Aug. 24, 2004, and entitled, “SUTURE MANIPULATIONSYSTEM WITH ROTATIONAL FINGERS,” and is a continuation-in-part of priornon-provisional application Ser. No. 10/803,406, filed Mar. 17, 2004,and entitled “EXPANDABLE NEEDLE SUTURE APPARATUS AND ASSOCIATED HANDLEASSEMBLY,” now issued as U.S. Pat. No. 8,066,718, which claims thebenefit of Provisional Application Ser. No. 60/455,859 filed on Mar. 18,2003, and entitled, “EXPANDABLE NEEDLE SUTURE APPARATUS AND METHOD,” andProvisional Application Ser. No. 60/500,046 filed on Sep. 3, 2003, andentitled, “EXPANDABLE NEEDLE SUTURE APPARATUS AND ASSOCIATED HANDLEASSEMBLY,” all of which are fully incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to surgical suture apparatus and, morespecifically, to needle and suture manipulating apparatus and methods.

2. Discussion of Related Art

One of the more challenging aspects of endoscopy/arthroscopy is toproperly place a suture in identified tissue. This task is complicatedby the fact that all work must be done through a 5-8 millimeter cannulawhile viewing one's efforts on a monitor.

With these difficult size configurations, it has been a significantchallenge to incorporate all of the tasks into a single instrument. As aresult, the tasks for initially passing a suture through target tissueand subsequently retrieving the suture from the far side has oftenrequired use of more than one instrument, especially when the suture ispositioned in an awkward or difficult to reach orientation relative tothe instrument being used to retrieve the suture.

Various needle configurations have been contemplated, some with theneedle permanently attached to the suture and others wherein the needlemerely engages the suture. Attempts to miniaturize the needle structurehave often produced needles that were so small they tended to yieldunder compressive stresses.

The handles associated with suturing devices have been limited in thenumber of functions that could be performed. In some cases, handleassemblies have required two-handed operation. It has also been typicalto provide needle assemblies that were permanently attached to thehandle rather than assemblies that were removable from the handle andperhaps disposable.

SUMMARY OF THE INVENTION

In one embodiment of the device contemplated, a needle assembly with asharp tip is shaped from a wire. The wire is partially sliced near thetip so that it has two bifurcated portions that define a slot. The wireis processed in a manner that permits these bifurcated portions to movebetween two positions. In a first position, the bifurcated portions arebiased to extend outwardly in which case the slot is generally open. Inthe second position, the bifurcated portions can be forced inwardly inwhich case the slot is substantially closed. As noted, the bifurcatedportions are biased outwardly so that the wire, in its relaxed positionhas an open slot.

In this expanded state, the open slot can be easily loaded with asuture. The needle assembly can then be pulled into a carrier tube thatcompresses the two bifurcated sides of the slot to shrink the profile ofthe distal tip and engage the loaded suture. With its sharp tip, theneedle assembly, compressed within the outer tube, can then be easilypassed with the suture through the tissue. On the other side of thetissue, the needle assembly can be deployed thereby permitting the slotto automatically expand in the relaxed state. This enlarges the slotthereby enabling the suture to be released. The needle assembly can thenbe removed from the tissue leaving the suture in place.

In one aspect of the invention, a surgical device extends along an axisand has a proximal end and a distal end. The device is operable to movea suture through body tissue and includes a shaft having a hollowconfiguration. A handle assembly is coupled to the shaft, and anactuating rod having a proximal end and a distal end is disposed toextend between the handle assembly and the shaft. A needle assembly isdisposed at the distal end of the actuating rod and is movable with theactuating rod between an extended position and a retracted position.Bifurcated portions of the needle assembly define a suture slot and havea proximate disposition when the actuating rod is in the retracted stateand a separated state when the actuating rod is in the extended state.The actuating rod is biased to the retracted position while thebifurcated portions are biased to the separated state.

In another aspect of the invention, a surgical suturing device includesa needle assembly with a needle movable in a needle housing between afree suture state and a captured suture state. A handle assemblyincludes a longitudinal handle housing sized and configured toreleasably receive the needle assembly. A thumb slide assembly isreleasably coupled to the needle and movable longitudinally on thehandle housing between a distal position and a proximal position. Thedistal position of the thumb slide assembly is associated with theneedle in the free suture state, while the proximal position of thethumb slide assembly is associated with the needle in one of a capturedstate and a locked state.

In another aspect, the invention includes a method for placing a sutureacross a body wall of a patient. Initially, a suturing device isprovided that includes a hollow shaft with a proximal end and a distalend, an actuating rod disposed in the shaft, and a needle assemblycarried by the rod. The arms are movable between a proximate dispositionassociated with a first slot size and a spaced disposition associatedwith a second slot size greater than the first slot size. The body wallis then penetrated, with the needle assembly in the retracted positionand the arms in the proximate disposition. The needle assembly can thenbe advanced to the deployed position to move the arms to the spaceddisposition associated with the second slot size.

These and other features and advantages of the invention will becomemore apparent with a description of preferred embodiments in referenceto the associated drawings.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is an axial cross section view of one embodiment of the presentinvention illustrating a bifurcated needle assembly;

FIG. 2 is an axial cross section view showing the needle assembly in aretracted position;

FIG. 3 is an enlarged view of the distal end of the device illustratedin FIG. 2;

FIG. 4-FIG. 9 illustrate steps in a method for using the suture deviceof FIG. 1;

FIG. 4 is a side elevation view illustrating the device in a normalstate with the needle assembly retracted;

FIG. 5 is a side elevation view showing operation of a thumb slide todeploy the needle assembly to an extended position characterized byautomatic formation of an enlarged slot in the needle assembly;

FIG. 6 is a side elevation view illustrating the loading of a sutureinto the slot of the needle assembly;

FIG. 7 is a side elevation view showing retraction of the needleassembly and capture of the loaded suture;

FIG. 8 is the side elevation view illustrating passage of the needleassembly and suture through tissue;

FIG. 9 is a side elevation view illustrating deployment of the needleassembly to the extended position to enlarge the slot and release thesuture prior to withdrawal of the device from the tissue;

FIG. 10 is a side elevation view showing a further embodiment whereinthe needle is fabricated at the proximal end of the slot;

FIGS. 11-14 illustrate a further embodiment wherein the needle isbifurcated at the distal end of the slot;

FIG. 11 is a side elevation view showing a backing arm and a gatheringarm widely separated to receive a suture;

FIG. 12 is a side elevation view illustrating the needle slightlyretracted;

FIG. 13 is a side elevation view showing the needle further retracted;

FIG. 14 is a side elevation view showing the needle fully retracted;

FIG. 15 is a side elevation view of an embodiment similar to FIG. 11,but including a built-in stop;

FIG. 16 is a side elevation view of a further embodiment wherein theneedle is tapered to facilitate manipulation through drastically benttubes;

FIG. 16A is a cross section view taken along lines 16A-16A of FIG. 16showing an embodiment with two arms;

FIG. 16B is a cross section view taken along lines 16B-16B of FIG. 16showing an embodiment with four arms;

FIG. 17 is a side elevation view of a further embodiment wherein ahelical slot is cut around the circumference of the needle;

FIGS. 18-22 illustrate a preferred method particularly applicable to theembodiment of FIG. 11;

FIG. 18 is a side elevation view showing the needle retracted and passedthrough the tissue;

FIG. 19 is a side elevation view showing the needle fully deployed toreceive the suture;

FIG. 20 is a side elevation view showing the needle retracted with thesuture disposed in the needle slot;

FIG. 21 is a side elevation view showing the needle removed from thetissue drawing the suture through the needle hole in the tissue;

FIG. 22 is a side elevation view showing the needle fully deployed torelease the suture from the needle leaving the suture extending throughthe tissue;

FIG. 23 is a side elevation view of a further embodiment of a needleassembly including a straight backing arm and a curved gathering arm;

FIG. 24 is a side elevation view of another embodiment including acurved gathering arm and a curved backing arm;

FIG. 25 is another embodiment of a needle assembly with angled portionsdefining a slot;

FIG. 26 is a further embodiment of the needle assembly with large andsmall diameter portions;

FIG. 27 is a side elevation view of another needle assembly including anotch in the needle tube;

FIG. 28 is a side elevation view illustrating a notch-free needle tubeand a needle in a suture-sliding position;

FIG. 29 is a side elevation view similar to FIG. 28 with the needle in asuture-locked position;

FIG. 30 is a side elevation view of a needle assembly having a bendablesection;

FIG. 31 is a perspective view of the needle assembly having a radius toprevent suture fraying;

FIG. 32 is a side elevation view of a needle assembly having an openinginto the suture slot;

FIG. 33 is a side elevation view illustrating the preferred dispositionof the opening;

FIG. 34 is a side elevation view illustrating a taper in the needlehousing;

FIG. 35 is a cross-section view of a preferred embodiment of a handleassembly;

FIGS. 36 a-36 d are progressive views of a structure and method forcoupling the needle assembly and the handle assembly;

FIGS. 37 a and 37 b are side elevation views illustrating use of a pinto restrict movement of a needle rod;

FIG. 38 is a perspective view of a needle assembly bifurcated by a slot;

FIG. 39 is a perspective view illustrating the needle of FIG. 38 in itsbifurcated configuration;

FIG. 40 is a side elevation view of an additional embodiment of abifurcated needle assembly;

FIG. 41 is a side elevation view of a further embodiment of a bifurcatedneedle assembly;

FIGS. 42-44 show the distal end of a further possible embodiments of asuture device that can retract and deploy the needle assembly and canrotate the needle assembly to different desired orientations afterdeployment to aid in the grasping of the suture;

FIG. 42 is a perspective view of the needle assembly in a standardstraight position;

FIG. 43 is a perspective view of the needle assembly after being rotatedabout 45°;

FIG. 44 is a perspective view of the needle assembly after being rotatedabout 135°;

FIG. 45 is a perspective view of a first embodiment of a suture devicethat uses a thumb wheel to deploy and rotate the needle assembly asshown in FIGS. 42-44;

FIG. 46 a is a perspective view of a second embodiment of a suturedevice that uses a thumb lever located within a lever channel to deployand rotate the needle assembly as shown in FIGS. 42-44;

FIG. 46 b is a closeup view of the lever channel of the suture deviceshown in FIG. 46 a;

FIG. 47 a is a perspective view of a third embodiment of a suture devicethat uses a thumb lever located within a movement-constraining leverchannel to deploy and rotate the needle assembly as shown in FIGS.42-44;

FIG. 47 b is a closeup view of the lever channel of the suture deviceshown in FIG. 47 a;

DESCRIPTION OF PREFERRED EMBODIMENTS

A suture device is illustrated in FIG. 1 and designated by the referencenumeral 10. The device is an elongate structure and includes a handle 12at its proximal end and a hollow shaft 14 at its distal end. Anactuating rod 16 is disposed within the hollow shaft 14 and extends fromthe handle 12 through the shaft 14. In the handle 12, the actuating rod16 is engaged by a thumb slide 18. At its distal end, the actuating rod16 is coupled to a needle assembly 20. This assembly 20 includes a sharptip 22 and bifurcated portions 24 and 26, which define a slit or slot 28proximately of the tip 22.

Operation of the thumb slide 18 relative to the handle 12 moves theactuating rod 16 and the attached needle assembly 20 between an extendedposition as illustrated in FIG. 1, and a retracted position asillustrated in FIGS. 2 and 3. In this particular embodiment, a spring 30is used to bias the rod 16 and needle assembly 20 proximally to theretracted position. It will also be noted with reference to FIG. 3 thatthe needle assembly 20 can be provided with shoulder stops 31 which areseparated by a width greater than the internal diameter of the shaft 14.These shoulder stops 31 prevent the distal tip 22 of the needle assembly20 from entering the shaft 14 in the retracted position.

The bifurcated portions 24 and 26 are also moveable between twopositions. In a first position, the bifurcated portions 24 and 26 areseparated radially to enlarge the slot 28. In a second position, thebifurcated portions 24 and 26 are brought into close proximately by thetube, closing the slot 28. In a preferred embodiment, these bifurcatedportions 24 and 26 are biased to the separated state as illustrated inFIG. 1 so the slot 28 automatically opens when the needle assembly 20 isin the extended position.

Operation of the suture device 10 is illustrated in FIGS. 4-9.Initially, the device 10 in a relaxed, stored state will have the needleassembly 20 biased to the retracted position as illustrated in FIG. 4.In order to initially load the device 10 with a suture 32, the needleassembly must be moved to the extended position as illustrated in FIG.5. This is accomplished by pushing the thumb slide 18 distally to forcethe actuating rod 16 and the needle assembly 20 in the distal direction.When the needle assembly 20 clears the distal end of hollow shaft 14,the bifurcated portions 24 and 26 are free to expand laterally therebyautomatically enlarging the slot 28 as illustrated in FIG. 5. With theslot 28 enlarged, the suture 32 can now be passed through the slot asillustrated if FIG. 6. Releasing the thumb slide 18 permits the spring30 to move the actuating rod 16 and needle assembly 20 proximally to theretracted position. As the needle assembly is drawn into the hollowshaft 14, the restricted radial dimension forces the bifurcated portions24 and 26 to move toward each other thereby closing the slot 28 andfully engaging the suture 32. In this retracted state, illustrated inFIG. 7, the device is now loaded and prepared for disposition throughthe patient's tissue, which is designated by the reference numeral 34 inFIG. 8. The actuating rod 16 can be biased to the retracted position sothat the device in the relaxed state automatically orients itself foruse in crossing the tissue 34 as illustrated in FIG. 8.

With the needle assembly 20 and the suture 32 extending through thetissue 34, it is now desirable to release the suture from the device 10.This is accomplished by again pushing the thumb slide distally to movethe needle assembly from the retracted position to the extendedposition. As before, the bias of the bifurcated portions 24 and 26 willpermit the needle assembly 20 to enlarge the slot 28 therebyfacilitating release of the suture 32 from the device 10. This isillustrated in FIG. 9. As a final step, the device 10 can be removedfrom the tissue 34 leaving the suture 32 operatively disposed across thetissue 34.

Notwithstanding the specific features of this embodiment, it will benoted that the needle assembly 20 includes a sharp point whichfacilitates passage through the tissue 34 even when the assembly 20 isin the retracted state. The bifurcated portions 24 and 26 function as agripping means which automatically opens to facilitate loading thesuture 32, but which is capable of being closed with a force sufficientto retain the suture in the slot 28 as the device 10 is pushed throughthe tissue 34. The hollow shaft 14 in this case functions primarily as avehicle for moving the bifurcated portions 24 and 26 between the openstate and the closed state. In the illustrated embodiment the hollowshaft 14 is shown with a straight configuration; but it can also beprovided with many different curved configurations to enhance usage invarious anatomically restricted areas. It will be apparent to thoseskilled in the art that this function can be accomplished by manydifferent structures in other embodiments of the concept.

In an additional embodiment illustrated FIG. 10, elements of structuresimilar to those previously discussed are designated with the samereference numeral followed by the lower case letter “a.” Thus, thisembodiment includes the actuating rod 16 a, needle assembly 20 a anddistal tip 22 a. In this case however, the bifurcated portions 24 and 26function as a backing arm 36 and gathering arm 38, respectively. Thegathering arm 38 can be integral with the backing arm 36 at the distalend of the slot 28 a, but preferably is separated from the backing arm36 at the proximal end of the slot 28 a. At this location, the gatheringarm 38 a is cut from the backing arm 36 a to form a passage 40, whichallows the needle to be more flexible as it is passed thru curves. Thepassage 40 can also facilitate drawing the suture into the slot 28 a ifthe passage 40 is exposed distal of the hollow shaft 14 a duringdeployment.

A similar embodiment is illustrated in FIGS. 11-14 wherein elements ofstructure similar to those previously discussed are designated with thesame reference numeral followed by the lower case letter “b.” In thisembodiment, the hollow shaft 14 b receives the actuating rod 16 b in themanner previously discussed. This embodiment also includes the backingarm 36 b as well as the gathering arm 38 b. However, in this case, thegathering arm 38 b is integral with the backing arm 36 b at the proximalend of the slot 28 b. The gathering arm 38 b is separated from thebacking arm 36 b at the distal end where a passage 42 permits the sutureto enter the slot 28 b. This passage 42 is cut along the gathering arm38 b so that a small portion of the arm 44 remains with the distal tip22 b. This enables the needle assembly 20 b to retain the suture withoutdamage when the needle assembly 20 b is fully retracted. The gatheringarm 38 b in this embodiment can be shaped in a variety of ways. In theillustrated example, three bends 46, 48 and 50 create a wide passage 42to facilitate capture of the suture.

In FIG. 12, the needle assembly 20 has been slightly retracted into thehollow shaft 14 b and the bend 46 has been generally straightened. Theangle of the bend 50 has created a lip that gathers the suture towardthe backing arm 36 b as the bend 46 is straightened by the hollow shaft14 b.

In FIG. 13, the needle assembly 20 b is even further retracted. This hascaused the bend 48 to straighten bringing the gathering arm 38 b intocontact with the backing arm 36 b while still maintaining the passage 42for the suture.

When fully retracted as illustrated in FIG. 14, the short portion 44 ofthe gathering arm 38 b is received in the hollow shaft 14 leaving asmall opening 52 to retain the suture.

A further embodiment is illustrated in FIG. 15 where elements ofstructure similar to those previously discussed are designated with thesame reference numeral followed by the lower case letter “c.” In thisembodiment, the backing arm 36 c also defines the slot 28 c with thegathering arm 38 c. In this embodiment, the gathering arm 38 c is alsocut to form the passage 42 c. However, the cut forming this passage 42 cforms an oblique angle with the length of the needle assembly 20 c sothat a stop 54 is formed at the distal end of the gathering arm 38 c.This stop 54 is formed with a proximal tang 56 on the gathering arm 38c, which interferes with a distal tang 54 on the short portion 44. It isthe purpose of this stop 54 to prevent the gathering arm 38 c fromcontacting the backing arm 36 c and thereby restricting free movement ofa captured suture.

Another embodiment is illustrated in FIGS. 16, 16A and 16B whereelements of structure similar to those previously discussed aredesignated with the same reference numeral followed by the lower caseletter “d”. In this embodiment, the horizontal slot 28 d is formedbetween the bifurcated portions 36 d and 38 d. With only the singlehorizontal slot 28 d, this embodiment has a cross-section such as thatillustrated in FIG. 16 a.

In a similar embodiment, a vertical slot 60 can be added, leaving theneedle assembly 20 d with four arms which are designated by thereference numerals 36 d′, 36 d″, 38 d′ and 38 d″ in FIG. 16B. Thisparticular configuration of the needle assembly 20 d allows manipulationthrough drastically bent tubes. Of course, any number of multiple armscould facilitate this advantage. A taper 62 can be formed at theproximal ends of the arms 36 d and 38 d. This tapered profile keeps thewalls of the needle assembly 20 d relatively consistent and flexible tominimize stress concentrations.

FIG. 17 illustrates a further embodiment wherein a helical slot 64 iscut around the circumference of a cylindrical needle 66. In this casethe helical slot 64 is adapted to receive the suture and to hide thesuture within the needle 66 as it penetrates the tissue. In thisparticular embodiment, the helical slot 64 may have a depth greater thanzero but preferably not greater than 0.75 times the radius of the needle66.

FIGS. 18-22 illustrate a method for using the needle assembly 20 andparticularly the needle assembly 20 b illustrated in FIG. 11.

In FIG. 18, the needle assembly 20 b has been retracted and the hollowshaft 14 b passed through the tissue 34 b. The suture 32 b is shown onthe far side of the tissue 34 b. With this disposition of the suturingdevice 10 b, the thumb slide 18 b can now be moved distally to deploythe bifurcated needle assembly 20 b as illustrated in FIG. 19. In thisposition, the suture 32 b can be introduced through the distal passage42 and into the slot 28 b. As the thumb slide 18 b is drawn proximally,the needle assembly 20 b is retracted into the hollow shaft 14 b in thematter discussed with reference to FIG. 14.

With the suture captured in the opening 52, as illustrated in FIG. 20,the suture device can be withdrawn from the tissue 34 b pulling thesuture 32 b through the needle hole left in the tissue 34 b. This stepin the process is illustrated in FIG. 21. Finally, the thumb slide 18 bcan again be moved distally to deploy the needle assembly 20 b. Thiswill produce a wide separation of the backing arm 36 b and gathering arm38 b resulting in release of the suture 32 b from the suture device 10b. In this manner, the suture 32 b can be threaded through the tissue 34b.

A further embodiment of the invention is illustrated in FIG. 23 wherethe needle assembly 20 is shown with a unique shape that enhancesperformance in some embodiments. In this case, the needle assembly 20includes a backing arm 70 and a gathering arm 72. The gathering arm 72is curved so that an opening is provided with minimal needle deploymentto facilitate capture of the suture. This feature enhances use of theneedle assembly 20 where the suture must be engaged in small spaces andthe needle cannot be fully deployed.

In FIG. 24, a similar embodiment is illustrated where the backing arm 70is also curved. In this manner, the needle assembly 20 can be providedwith a shape that is closer to that of the hollow shaft 14 (FIG. 1).This embodiment is representative of a concept wherein the hollow shaftcan have many different curved configurations, each adapted for aparticular anatomical area or indication; and the associated needleassembly including the backing arm 70 and gathering arm 72 can bematched to the configuration of the shaft.

FIGS. 25 and 26 show two variations where the needle assembly 20includes a thick needle section 74 that is proximal of a pointed end 76.In these embodiments, the thick needle section 74 defines a portion ofthe suture slot 67 that, as previously noted, can have a variety ofconfigurations. Proximal of the thick section 74, a diameter can be madesmaller so that a thinner section 78 is created. This thin section 78makes it easier for the needle to be moved through the curves of thehollow shaft 14.

In the embodiment of FIG. 27, a notch 81 is created in the distal end ofthe hollow tube 63. This notch 81, in connection with a needle tip 64,creates a suture slot 83 which holds the suture. With the notch 81buried in the hollow tube 63, the needle tip 64 can be made shorter sothat a curved device can have a lower profile adapting it for use in asmaller diameter cannula.

FIGS. 28 and 29 illustrate two positions of a needle tip 64 relative toa hollow tube 65. In these two positions, the size of the suture slot 66can differ. The suture slot 66 in FIG. 28 is sufficiently large toenable the suture to slide or slip easily relative to the hollow tube65. By comparison, the suture slot 66 in FIG. 29 is relatively smallbecause the needle tip 64 has been retracted slightly into the hollowtube 65. In this second position, the needle tip 64 is retracted toreduce the size of the suture slot 66 and hold or lock the suture inplace against the hollow tube 65. A variety of mechanisms can be used toprovide various detented positions between the first positionillustrated in FIG. 28 and the second position illustrated in FIG. 29. Amechanism could also be provided to require a force of progressivemagnitude in order to move between the slipping position of FIG. 28 andthe locking position of FIG. 29.

In some cases it is advantageous to provide the hollow shaft 14 with adrastically bent configuration. Under these circumstances, a needleassembly 20 formed from a metal material such a Nitinol, can be made toslide more easily within the drastically bent tube if it is made thinnerat those locations where it is to be bent during deployment orretraction. The distal end of the needle assembly 20 can be kept largerso that the diameter of the needle tip is sufficiently thick towithstand any bending stresses. The proximal end need not be madethicker since it functions primarily as a push/pull rod incompression/tension during deployment and retraction.

FIG. 30 shows an example of a tapered needle that can be provided in amultitude of configurations. Beginning generally at the distal end, theneedle 90 can be provided with a distal taper 81. This taper can startat any location between a point just proximal of the needle point to alocation just proximal of the slot. In the latter location, the startingposition tends to maximize the amount of material defining the slot.Depending on the strength required, a proximal taper 83 can also beprovided back to the diameter of the needle point. This proximal taper83 would be of particular advantage where a thicker shaft might berequired for strength purposes.

As illustrated in FIG. 31, many of the foregoing embodiments can benefitfrom a radius 92 provided in the distal end of the slot. Such a radius92 will insure that a sliding suture is less likely to be frayed on asharp edge.

In the embodiment of FIG. 32, an opening 94 is provided between twotangs 96 and 98, which also define the needle slot. This opening 94 ispreferably defined at a location that is more distal along the slot sothat it can be exposed when the needle is only slightly deployed fromthe needle tube. Thus, even with a slight deployment of the needle, asuture can be slid through the opening 94 and into the slot. This can beof particular importance in an embodiment wherein the suture is veryclose to where the needle exits the tissue. Under these circumstances,it would be more difficult to capture the suture if the needle had to befully deployed. Notwithstanding the preferred distal location of theopening 94 relative to the slot, it is desirable that the opening 94 bepositioned sufficiently proximally that a basin 96 is formed at theproximal end of the slot, as illustrated in FIG. 33.

FIG. 34 illustrates an embodiment wherein a hollow tube housing 101 isprovided with a taper 103 at its distal end. This taper 103 will tend tominimize the insertion forces required for the device.

A handle assembly 110 is illustrated in FIG. 35 as a preferredembodiment of the handle 12 discussed with reference to FIG. 1. In themanner previously discussed, the handle assembly 110 is adapted toreceive the needle assembly 20, including the hollow shaft 14 and therod 16. In addition, the needle assembly 20 in this embodiment isprovided with a hub 112 having an enlargement 114 and a cylindricalextension 116 disposed proximally of the enlargement 74.

In this embodiment, the handle assembly 110 includes a frame 118, andthe thumb slide 18 that can be moved by a thumb of the user. In thismanner, the thumb slide 18 can be moved between a rearward position, tothe left in FIG. 35, and a forward position, illustrated to the right inFIG. 35.

The thumb slide 18 is part of a unit that moves in combination with aslider 121 and a needle latch 123. The needle latch 123 is rotatable onthe slider 121 about a pivot pin 125, and includes a leaf spring 127. Atooth 130 is also carried by the slider 121 and cooperates with a slot132 and ratchet 134 in the frame 118.

A locking lever 136 is pivotal on the frame 118 at a pivot pin 138. Thisenables the locking lever 136 to move as shown by an arrow 141 betweenan unlocking position and a locking position illustrated in FIG. 35.

A lever latch 143 is biased by a spring 145 to lock the locking lever136 in the locking position illustrated in FIG. 35. Movement of thelever latch 143 longitudinally along an arrow 144 and against the biasof the coil spring 145 frees the locking lever 136 to move from theillustrated locking position to the unlocking position under the bias ofa coil spring 147.

When the locking lever 136 is in the unlocking position, a hub lock 150is removed from proximity with the hub 112 of the needle assembly 20.This enables the cylindrical extension 116 of the needle assembly 20 tobe inserted into and removed from a channel 152 at the distal end of thehandle assembly 110. With the hub 112 inserted into the channel 152, thelocking lever 136 can be moved to its locking position where the hublock 150 engages a slot 154 in the cylindrical extension 116. The leverlatch 143 automatically retains the locking lever 136 in the lockingposition illustrated in FIG. 35.

In order to initially prepare for operation of the suture device 10, theremovable needle assembly 20 must be mounted in the handle assembly 110.For purposes of discussion, it will be assumed that the thumb slide 18is pushed forward into the distal position illustrated in FIG. 35.

As an initial step in the mounting process, the locking lever 136 ismoved to the unlocked position, downwardly along the arrow 141 in FIG.35. This is accomplished by moving the lever latch 143 rearwardly orproximally to the left in FIG. 35. This movement, against the bias ofthe coil spring 145, will cause the lever latch 143 to disengage thelocking lever 136, which will then automatically drop to the unlockingposition under the bias of the coil spring 147.

With the hub lock 150 withdrawn from the slot 154, the cylindricalextension 152 of the needle assembly 20 can be moved into the channel152 along with the needle rod 16. With the needle assembly 20 insertedand the enlargement 114 butted against the handle assembly 110, a notch155 at the proximal end of the needle rod 16 will engage the needlelatch 123. At this point, the locking lever 136 can be closed againstthe bias of the spring 147 causing the hub lock 150 to engage the slot154 in the cylindrical extension 152. The closing of the locking lever136 also provides a positive force through the leaf spring, whichmaintains the needle latch 123 in the notch 155. As the locking lever136 moves upwardly to the locking position, the coil spring 145 willbias the lever latch 143 to engage, lock, and retain the locking lever136 in the locking position. In this operating position, movement of thethumb slide 18 relative to the frame 118 will cause the needle rod 16 tomove relative to the hub 114 of the needle assembly 20.

The foregoing procedure for mounting the needle assembly 20 into thehandle assembly 110 was begun with the assumption that the thumb slide18 would be in the forward, distal position. If this is not the case,the needle latch 123 will not initially engage the proximal end of theneedle rod 16. Even under these circumstances, the mounting operationcan be completed in the foregoing manner so that the hub 114 is retainedby the locking lever 136, which is in turn locked by the lever latch143. With this step completed, the thumb slide 18 can be slid forward inthe distal direction to enable the needle latch 123 to engage the notch155 at the proximal end of the rod 16. This engagement and locking ofthe rod 16 by the needle latch 123 will be accommodated by deflection ofthe leaf spring 127. In accordance with either of these processes, theneedle assembly 20 can be coupled to the handle assembly 110 andprepared for use by the surgeon.

In operation, the suture 32 can be positioned between the bifurcatedportions 24 and 26 of the needle when the needle is deployed. At thispoint the needle assembly 20 can be fully deployed by moving the thumbslide 10 and the rod 16 distally. In this position of the needleassembly 20, the suture 32 can be loaded, unloaded, picked up, ordropped off as required in different stages of operation.

With the suture 32 thus loaded in the needle assembly 20, the surgeoncan pull the thumb slide 18 proximally, rearwardly until the tooth 130on the slider 121 engages the slot 132 on the frame 118. In thisposition, the suture 32 is captured within the needle but is still freeto slide laterally in the slot of the needle. Note that the springinessof the thumb slide 18 forces the tooth 130 to remain in the slot 132where it is held in contact with the frame 78.

If it becomes desirable to further engage the suture 32 and eliminateits ability to slide within the needle slot, the thumb slide 18 can bedepressed and further retracted causing the tooth 130 to leave the slot132 and move further rearwardly along the ratchet 134. This slightmovement will cause the rod 16 of the needle assembly 20 to move furtherrearwardly drawing the needle assembly 20 slightly further into thehollow shaft 14. In this position, the suture 32 is not only capturedwithin the needle assembly 20, but is sandwiched and locked between theneedle assembly 20 and the hollow shaft 14. During operation of thedevice 10, the thumb slide 18 in this embodiment is not intended to movefurther rearwardly.

As it becomes of interest in different stages of operation, the suture32 can be disengaged by moving the thumb slide 18 from thisrearward-most position, forwardly and distally. If the thumb slide isnot depressed, the tooth 130 will fall back into the slot 132 where thesuture is captured but nevertheless free to slide within the needle eye.In this position, the suture 32 can be removed. By depressing the thumbslide 18 the tooth 130 can be removed from the slot 132 permitting thethumb slide 18 to be moved further in the distal direction. This distalmovement will open the bifurcated portions 24 and 26 of the needleassembly 20 and fully releasing the suture 32.

Once the fully operative procedure is completed, the needle assembly 20can be removed from the handle assembly 110 by reversing the mountingsteps previously discussed.

A preferred structure for releasably engaging the needle rod 16 with theneedle latch 123 is illustrated in the progressive views of FIGS.36A-36D. In these views it is shown that the notch 155 can be formedwith a ramp 156 that is machined into the proximal end of the needle rod16. This ramp 156 allows the needle rod 16 to be pushed into the handleassembly 110 when the enlargement 114 of the hub 112 butts against thehandle assembly 110, the proximal end of the needle rod 16 can ride upover a ramp 158 on the needle latch 123 as illustrated in FIG. 36B. Whenfully seated as illustrated FIG. 36C, this locking mechanism keeps theneedle assembly attached to the handle assembly until the ramp 158 ismoved laterally permitting the ramp 156 and associated needle rod 16 tobe moved distally.

Apparatus for restricting the range of needle movement between itsretracted position and its forward position is illustrated in FIGS. 37Aand 37B. In this embodiment, a pin 161 is provided for disposition in atransverse slot 163 within the hub 112. In this embodiment, the rod 16of the needle assembly 20 is also provided with a channel 165 ofpredetermined length. In this sub-assembly, the rod 16 is initiallypositioned to extend longitudinally through the hub 112. When thechannel 165 intersects the slot 163, the pin 161 can be insertedlongitudinally through the slot 163 in the hub 112 and transverselythrough the channel 165 in the rod 16. This sub-assembly is illustratedin FIG. 37B. The restricted movement provided by this sub-assembly isneeded so that the needle is always in a position to be loaded into thehandle. With the accommodation of this restricted movement, the needlecannot be jammed in the handle assembly 110.

Another unique needle configuration is illustrated the prospective viewsof FIGS. 38 and 39. In this embodiment, the distal slot is similar tothat previously discussed, but the distal tip is bifurcated by a cut 167that extends into the slot. In operation, deployment of the needlecauses the bifurcated portions 169 and 170 to split, as illustrated inFIG. 39. Of course there are many variations of this bifurcatedconfiguration. Two such variations are illustrated in FIGS. 40 and 41.By way of comparison, it will be noted that the cut 167 in FIG. 38 isdisposed along the axis of the needle tip so that the tip portions aresymmetrical. In the views of FIGS. 40 and 41, the cut 167 does notproduce symmetrical tip portions. Although the cut is planar in FIG. 41and in FIG. 38, it is nevertheless offset from the axis of the tip inFIG. 40. In the embodiment in FIG. 41, the cut 167 is non-planar.

FIGS. 42-47 relate to alternative embodiments of the present inventionthat include an actuator assembly that offers a rotational controlfeature. Here, the needle assembly may be deployed from the distal endof the hollow shaft by manipulating the actuating rod at the proximalend of the hollow shaft using a suitable thumb actuator assembly. Usingthis same base design, the ability is added such that when the needleassembly is deployed, its arms can also be rotated to get into a betterposition to grab the suture. The needle assembly can then be rotatedback to the original position, if desired, and drawn back in the hollowshaft for withdrawal.

FIGS. 42-44 show the distal end of a further possible embodiment of asuture device that can retract and deploy the needle assembly and canrotate the needle assembly to different desired orientations afterdeployment to aid in the grasping of suture. In particular, FIGS. 42-44show sample positions of rotation after a needle assembly 220 having twoarms 226, 228 has been deployed from the hollow shaft 214. In FIG. 42,the needle assembly 220 is in the standard straight position. In FIG.43, the needle assembly 220 has been rotated about 45°, as suggested bythe arrow, and in FIG. 44, the needle assembly 220 has been rotatedabout 135°. This rotation can also occur with the needle assembly onlypartially deployed.

The rotational action is controlled by providing the user with asuitable control mechanism at the proximal end of the hollow shaft 214containing the needle assembly 220. There are a variety of possiblemethods to rotate the needle assembly.

FIG. 45 shows one example of a suture device 210 that includes thisrotational enhancement. In particular, FIG. 45 is a perspective view ofa first embodiment of a suture device 210 that uses a thumb wheel 218 todeploy and rotate the needle assembly 220 as shown in FIGS. 42-44

As shown, a handle 212 is attached to hollow shaft 214. Running thelength of the shaft 214 is an actuating rod 216 which has its proximalend attached to the thumb wheel 218, and which terminates in split arms226, 228 at its distal end. The thumb wheel 218 can be used to deployand retract the split arms 226, 228 relative to the hollow shaft 214with the reciprocating motion suggested by arrow 204. At any time, thethumb wheel 218 can also be rotated as suggested by arrow 205, whichrotation translates along the actuating rod 216 and moves the split arms226, 228 of the needle assembly 220 in a circular motion suggested byarrow 206.

FIGS. 46 a and 46 b show another embodiment that uses a handle 212having a thumb lever 318 moveable within a lever channel 319. FIG. 46 bis a blown-up view of the top of the lever channel 319. The lever 318can deploy and retract the split arms 226, 228 from the hollow shaft 214when moved in a back-and-forth direction represented by arrow 304. Thelever 318 can also move in a left-and-right direction represented byarrow 305. As best shown in FIG. 46 b, the lever 318 can move fartherand farther in the left-and-right direction as the lever 318 is movedmore distally within lever channel 319. The side-to-side motion 305translates to the split arms 226, 228 and creates a substantiallyrotational movement as described by arrow 306. As the split arms 226,228 are retracted by pulling the lever 318 proximally, the side-to-sidemotion 305 permitted within lever channel 319 becomes lessened until theproximal slot 311 is reached, at which point the side-to-side movement305 is near zero. The taper described by the lever channel 319 allowsmore side-to-side movement 305 when the lever 318 is deployed distallyso that the split arms 226, 228 can rotate more 306 as they are deployedfurther. Conversely, as the lever 318 is pulled proximally, theside-to-side movement 305 is restricted to help prevent the split arms226, 228 from being overstressed in the near closed positions. Withinthe movement defined by the proximal slot 311 there may be one or moredetents or over-ridable stops that position and hold the split arms 226,228 at a defined position relative to the hollow shaft 214.

FIGS. 47 a and 47 b are similar to FIGS. 46 a and 46 b in that they showanother embodiment that uses a handle 412 having a thumb lever 418moveable within a lever channel 419. Here, however, the lever channel419 defines the movement of the lever 418. There are many ways this canbe done but, in this example, the lever 418 is allowed to deploy andretract the split arms 226, 228 by being moved along a central slot 419a. At the distal end, a cross slot 419 b allows side-to-side motion ofthe thumb lever 419. The lever channel 419 may also include additionalslots for locking the split arms 226, 228 in a defined location relativeto the hollow shaft 214. In the illustrated embodiment, the first slotis a suture sliding slot 419 c and the other is a suture locking slot419 d. When the lever 418 is positioned in the suture sliding slot 419c, a small gap is left between the hook of the split arm 226 and thehollow shaft 214 to allow free sliding of captured suture. When thelever 418 is positioned in the suture locking slot 419 d, the gap islessened so that the captured suture can not move freely.

Although the invention has been discussed with reference to specificembodiments, it will be apparent that the concept can be otherwiseembodied to achieve the advantages discussed.

The invention claimed is:
 1. A surgical device extending along an axisand having a proximal end and a distal end, the device being operable tomove a suture through body tissue, comprising: an elongate shaft havinga hollow configuration; a longitudinal handle assembly coupled to theshaft; an actuating rod having a proximal end and a distal end, theactuating rod being disposed to extend between the handle assembly andthe shaft and capable of moving both axially along the axis androtationally about the axis; a needle assembly disposed at the distalend of the actuating rod and movable with the actuating rod between anextended state and a retracted state along the axis and to desiredangular states about the axis; a thumb actuator assembly operativelyconnected to the proximal end of the actuating rod, the thumb actuatorassembly located on and extending from a side of the longitudinal handleassembly, near a distal end of the longitudinal handle assembly, andmovable longitudinally on the side of the longitudinal handle assemblybetween a distal position and a proximal position and between a firstlateral position and a second lateral position, and wherein the thumbactuator assembly comprises a thumb wheel that slides axially along theaxis and rotates angularly about the axis for moving the needle assemblybetween the extended state and the retracted state alone the axis andthe desired angular states about the axis; bifurcated portions of theneedle assembly defining a suture slot, the bifurcated portions having aproximate relationship when the needle assembly is in the retractedstate and having a separated relationship when the actuating rod is inthe extended state; the needle assembly being biased to the retractedstate; and the bifurcated portions being biased to the separatedrelationship.
 2. The surgical device recited in claim 1 furthercomprising: a sharp needle included in the needle assembly and disposeddistally of the bifurcated portions.
 3. The surgical device recited inclaim 1 wherein the bifurcated portions include a backing arm and agathering arm that define the suture slot with a proximal end and adistal end.
 4. The surgical device recited in claim 3 wherein portionsof the gathering arm define a passage into the suture slot.
 5. Thesurgical device recited in claim 4 wherein the passage defined by theportions of the gathering arm is disposed closer to the proximal end ofthe suture slot than the distal end of the suture slot.
 6. The surgicaldevice recited in claim 4 wherein the passage defined by the portions ofthe gathering arm is disposed closer to the distal end of the sutureslot than the proximal end of the suture slot.
 7. The surgical devicerecited in claim 3 wherein the bifurcated portions of the needleassembly have an outer surface in the shape of a cylinder.
 8. Thesurgical device recited in claim 1 wherein the bifurcated portions arefirst bifurcated portions defining a first slot, and the device furthercomprises: second bifurcated portions included in the needle assemblyand defining a second suture slot.
 9. The surgical device recited inclaim 1 wherein the suture slot has a tapered configuration.
 10. Thesurgical device recited in claim 6 wherein the gathering arm in theretracted position of the needle assembly is free to contact the backingarm.
 11. The surgical device recited in claim 6, wherein: the passage isdefined by a proximal portion of the gathering arm and a distal portionof the gathering arm, and the needle assembly further comprises: a stopformed on the distal portion of the gathering arm to prevent theproximal portion of the gathering arm from contacting the backing arm inthe retracted position of the needle assembly.
 12. The surgical devicerecited in claim 7 wherein at least one of the proximal end and distalend of the slot is rounded to inhibit suture damage.
 13. A surgicalsuturing device, comprising: a needle assembly having a needle movablein a needle housing between a free suture state and a captured suturestate; a handle assembly including a longitudinal handle housing sizedand configured to releasably receive the needle assembly; a thumbactuator assembly releasably coupled to the needle, the thumb actuatorassembly located on and extending from a side of the longitudinal handlehousing, near a distal end of the longitudinal handle housing, andmovable longitudinally on the side of the longitudinal handle housingbetween a distal position and a proximal position and between a firstlateral position and a second lateral position, wherein the thumbactuator assembly comprises a thumb wheel that slides axially along thesurgical suturing device's axis and rotates angularly about the surgicalsuturing device's axis; the distal position of the thumb actuatorassembly being associated with the needle in the free suture state; theproximal position of the thumb actuator assembly being associated withthe needle in the captured suture state; the first lateral position ofthe thumb actuator assembly being associated with the needle in a firstangular position; and the second lateral position of the thumb actuatorassembly being associated with the needle in a second angular position.14. A surgical suturing device, comprising: a needle assembly having aneedle movable in a needle housing between a free suture state and acaptured suture state; a handle assembly including a longitudinal handlehousing sized and configured to releasably receive the needle assembly;a thumb actuator assembly releasably coupled to the needle, the thumbactuator assembly located on and extending from a side of thelongitudinal handle housing, near a distal end of the longitudinalhandle housing, and movable longitudinally on the side of thelongitudinal handle housing between a distal position and a proximalposition and between a first lateral position and a second lateralposition, wherein the thumb actuator assembly comprises a thumb leverthat moves axially along the surgical suturing device's axis and thatmoves side-to-side about the surgical suturing device's axis, whereinthe thumb actuator assembly further comprises a lever channel thatconstrains the movement of the thumb lever, and wherein the leverchannel is geometrically configured to permit more side-to-side movementof the thumb lever when the thumb lever is positioned distally withinthe lever channel than when the lever is positioned proximally withinthe lever channel; the distal position of the thumb actuator assemblybeing associated with the needle in the free suture state; the proximalposition of the thumb actuator assembly being associated with the needlein the captured suture state; the first lateral position of the thumbactuator assembly being associated with the needle in a first angularposition; and the second lateral position of the thumb actuator assemblybeing associated with the needle in a second angular position.
 15. Asurgical suturing device, comprising: a needle assembly having a needlemovable in a needle housing between a free suture state and a capturedsuture state; a handle assembly including a longitudinal handle housingsized and configured to releasably receive the needle assembly; a thumbactuator assembly releasably coupled to the needle, the thumb actuatorassembly located on and extending from a side of the longitudinal handlehousing, near a distal end of the longitudinal handle housing, andmovable longitudinally on the side of the longitudinal handle housingbetween a distal position and a proximal position and between a firstlateral position and a second lateral position, wherein the thumbactuator assembly comprises a thumb lever that moves axially along thesurgical suturing device's axis and that moves side-to-side about thesurgical suturing device's axis, wherein the thumb actuator assemblyfurther comprises a lever channel that constrains the movement of thethumb lever, and wherein the lever channel comprises a central slot thatpermits axial motion of the thumb lever and a cross slot at a distal endof the central slot that allows side-to-side motion of the thumb lever;the distal position of the thumb actuator assembly being associated withthe needle in the free suture state; the proximal position of the thumbactuator assembly being associated with the needle in the capturedsuture state; the first lateral position of the thumb actuator assemblybeing associated with the needle in a first angular position; and thesecond lateral position of the thumb actuator assembly being associatedwith the needle in a second angular position.
 16. The surgical suturingdevice recited in claim 15 wherein the lever channel further comprises aslot for locking the needle assembly in a defined location relative to adistal end of the needle housing.
 17. A surgical device extending alongan axis and having a proximal end and a distal end, the device beingoperable to move a suture through body tissue, comprising: an elongateshaft having a hollow configuration; a longitudinal handle assemblycoupled to the shaft; an actuating rod having a proximal end and adistal end, the actuating rod being disposed to extend between thehandle assembly and the shaft and capable of moving both axially alongthe axis and rotationally about the axis; a needle assembly disposed atthe distal end of the actuating rod and movable with the actuating rodbetween an extended state and a retracted state along the axis and todesired angular states about the axis; a thumb actuator assemblyoperatively connected to the proximal end of the actuating rod, thethumb actuator assembly located on and extending from a side of thelongitudinal handle assembly, near a distal end of the longitudinalhandle assembly, and movable longitudinally on the side of thelongitudinal handle assembly between a distal position and a proximalposition and between a first lateral position and a second lateralposition, wherein thumb actuator assembly comprises a thumb lever thatmoves axially along the axis and that moves side-to-side about the axisand a lever channel that constrains the movement of the thumb lever, andwherein the lever channel is geometrically configured to permit moreside-to-side movement of the thumb lever when the thumb lever ispositioned distally within the lever channel than when the lever ispositioned proximally within the lever channel, wherein movement ofthumb lever axially along the axis and side-to-side about the axis movesthe needle assembly between the extended state and the retracted statealong the axis and the desired angular states about the axis; bifurcatedportions of the needle assembly defining a suture slot, the bifurcatedportions having a proximate relationship when the needle assembly is inthe retracted state and having a separated relationship when theactuating rod is in the extended state; the needle assembly being biasedto the retracted state; and the bifurcated portions being biased to theseparated relationship.
 18. A surgical device extending along an axisand having a proximal end and a distal end, the device being operable tomove a suture through body tissue, comprising: an elongate shaft havinga hollow configuration; a longitudinal handle assembly coupled to theshaft; an actuating rod having a proximal end and a distal end, theactuating rod being disposed to extend between the handle assembly andthe shaft and capable of moving both axially along the axis androtationally about the axis; a needle assembly disposed at the distalend of the actuating rod and movable with the actuating rod between anextended state and a retracted state along the axis and to desiredangular states about the axis; a thumb actuator assembly operativelyconnected to the proximal end of the actuating rod, the thumb actuatorassembly located on and extending from a side of the longitudinal handleassembly, near a distal end of the longitudinal handle assembly, andmovable longitudinally on the side of the longitudinal handle assemblybetween a distal position and a proximal position and between a firstlateral position and a second lateral position, wherein a lever channelcomprises a central slot that permits axial motion of a thumb lever anda cross slot at a distal end of the central slot that allowsside-to-side motion of the thumb lever, wherein movement of the thumblever axially along the distal and proximal positions and between thefirst lateral and second lateral positions moves the needle assemblybetween the extended state and the retracted state along the axis andthe desired angular states about the axis; bifurcated portions of theneedle assembly defining a suture slot, the bifurcated portions having aproximate relationship when the needle assembly is in the retractedstate and having a separated relationship when the actuating rod is inthe extended state; the needle assembly being biased to the retractedstate; and the bifurcated portions being biased to the separatedrelationship.
 19. The surgical device recited in claim 18 wherein thelever channel further comprises a slot for locking the needle assemblyin a defined location relative to a distal end of the elongate shaft.